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AliveDx Seeks US FDA’s 510(k) Clearance for MosaiQ AiPlex Multiplex Microarray

Shots:

  • The US FDA has received 510(k) Application for MosaiQ AiPlex Multiplex Microarray to improve & accelerate diagnosis of celiac disease
  • MosaiQ simplifies serological evaluation with syndromic approach by combining IgA & IgG isotypes to detect IgA deficiency & measure anti-tTG as well as anti-DGP (AU/mL) using just 20 μL of sample in single step, while the CD microassay incl. 5 markers in panel per pts incl. most auto-Abs for detection
  • MosaiQ allows a simple workflow with rapid results, detecting ~425 celiac disease markers/hr. with RFID-tagged reagents & loaders accelerating the processes to reduce time, consumables, & errors while improving calibration, quality control, & lab efficiency

Ref: AliveDx | Image: AliveDx

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